TY - JOUR

T1 - Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk

AU - Søndergaard, Lars

AU - Ihlemann, Nikolaj

AU - Capodanno, Davide

AU - Jørgensen, Troels H.

AU - Nissen, Henrik

AU - Kjeldsen, Bo Juel

AU - Chang, Yanping

AU - Steinbrüchel, Daniel Andreas

AU - Olsen, Peter Skov

AU - Petronio, Anna Sonia

AU - Thyregod, Hans Gustav Hørsted

PY - 2019/2

Y1 - 2019/2

N2 - Background: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and intermediate or high surgical risk. Objectives: The aim of this study was to compare the durability of transcatheter and surgical bioprosthetic aortic valves using standardized criteria. Methods: In the NOTION (Nordic Aortic Valve Intervention) trial, all-comer patients with severe aortic stenosis and lower surgical risk for mortality were randomized 1:1 to TAVR (n = 139) or SAVR (n = 135). Moderate/severe structural valve deterioration (SVD) was defined as a mean gradient ≥20 mm Hg, an increase in mean gradient ≥10 mm Hg from 3 months post-procedure, or more than mild intraprosthetic aortic regurgitation (AR) either new or worsening from 3 months post-procedure. Nonstructural valve deterioration (NSVD) was defined as moderate/severe patient-prosthesis mismatch at 3 months or moderate/severe paravalvular leakage. Bioprosthetic valve failure (BVF) was defined as: valve-related death, aortic valve reintervention, or severe hemodynamic SVD. Results: At 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58). The rate of SVD was higher for SAVR than TAVR (24.0% vs. 4.8%; p < 0.001), whereas there were no differences in NSVD (57.8% vs. 54.0%; p = 0.52) or endocarditis (5.9% vs. 5.8%; p = 0.95). BVF rates were similar after SAVR and TAVR through 6 years (6.7% vs. 7.5%; p = 0.89). Conclusions: In the NOTION trial through 6 years, SVD was significantly greater for SAVR than TAVR, whereas BVF was low and similar for both groups. Longer-term follow-up of randomized clinical trials will be necessary to confirm these findings. (Nordic Aortic Valve Intervention Trial; NCT01057173)

AB - Background: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and intermediate or high surgical risk. Objectives: The aim of this study was to compare the durability of transcatheter and surgical bioprosthetic aortic valves using standardized criteria. Methods: In the NOTION (Nordic Aortic Valve Intervention) trial, all-comer patients with severe aortic stenosis and lower surgical risk for mortality were randomized 1:1 to TAVR (n = 139) or SAVR (n = 135). Moderate/severe structural valve deterioration (SVD) was defined as a mean gradient ≥20 mm Hg, an increase in mean gradient ≥10 mm Hg from 3 months post-procedure, or more than mild intraprosthetic aortic regurgitation (AR) either new or worsening from 3 months post-procedure. Nonstructural valve deterioration (NSVD) was defined as moderate/severe patient-prosthesis mismatch at 3 months or moderate/severe paravalvular leakage. Bioprosthetic valve failure (BVF) was defined as: valve-related death, aortic valve reintervention, or severe hemodynamic SVD. Results: At 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58). The rate of SVD was higher for SAVR than TAVR (24.0% vs. 4.8%; p < 0.001), whereas there were no differences in NSVD (57.8% vs. 54.0%; p = 0.52) or endocarditis (5.9% vs. 5.8%; p = 0.95). BVF rates were similar after SAVR and TAVR through 6 years (6.7% vs. 7.5%; p = 0.89). Conclusions: In the NOTION trial through 6 years, SVD was significantly greater for SAVR than TAVR, whereas BVF was low and similar for both groups. Longer-term follow-up of randomized clinical trials will be necessary to confirm these findings. (Nordic Aortic Valve Intervention Trial; NCT01057173)

KW - aortic bioprosthesis

KW - aortic stenosis

KW - aortic valve durability

KW - transcatheter aortic valve replacement

UR - http://www.scopus.com/inward/record.url?scp=85060549135&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2018.10.083

DO - 10.1016/j.jacc.2018.10.083

M3 - Journal article

C2 - 30732707

AN - SCOPUS:85060549135

VL - 73

SP - 546

EP - 553

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 5

ER -